Comparison of sample collection tubes for microsampling

• Research type

  Research Study

• Full title

  COMPARISON OF CAPILLARY SAMPLES VERSUS STANDARD VENOUS SAMPLING METHODS WITH A VIEW TO USE THEM IN UNDERSERVED POPULATIONS.

• IRAS ID

  319511

• Contact name

  Karen Perkins

• Contact email

  karen.perkins@mbht.nhs.uk

• Sponsor organisation

  R&D, UHMBT

• Duration of Study in the UK

  0 years, 8 months, 31 days

• Research summary

  Health inequalities and access to healthcare, in particular diagnostic testing has been addressed by Public Health England with a report entitled ‘Blood Tests for people with learning disabilities: making reasonable adjustments.’ People over 14 years old with a learning disability (LD) are entitled to annual health checks with their GP. Currently less than 50 % of this population are achieving this. Routine blood testing can be prohibitive for people with LD or other cause of needle phobia or patients with poor venous access.
  Standard collection of blood will be done as part of routine clinical assessments in primary care patients. In addition, a second whole blood microsample will be collected at the same time, following informed consent from the patient. Patient care depending on venous sample results will not change in any way. Approximately 20 – 40 paired samples will be obtained for each analyte. Reduced volume of samples used on our laboratory automated analysers will be reduced to maximise the number of tests we can measure on one microsample. Lower volume limits will be established for clinically preferred combinations of tests (eg. liver function panel, renal panel, thyroid function tests). Any result bias between venous and microsamples will be statistically assessed for clinical significance and acceptability of bias. Precision (reproducibility) of test results from microsamples will also be compared to that obtained from standard venous samples. We aim to provide a verified toolkit of blood collection devices for taking microsamples from capillary veins for these underserved patient groups to enable routine health checks and therapeutic drug monitoring using smaller than routine analytical sample volumes.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  22/PR/1568

• Date of REC Opinion

  20 Feb 2023

• REC opinion

  Further Information Favourable Opinion